- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903159
Piloting "Positive Peer Journaling" a Journaling Practice to Support Recovery From Addiction (PPJ)
August 2, 2021 updated by: University of Minnesota
Addiction Recovery in a Rural Minnesota Community: Piloting "Positive Peer Journaling" Part II
The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery.
A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes.
The primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use.
The investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Saint Louis Park, Minnesota, United States, 55416
- Wayside Women's Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- minimum 18 years of age,
- meet DSM-V criteria for past-year SUD as primary or secondary diagnosis,
- English literacy sufficient to make short written lists needed to complete PPJ and homework assessments,
- minimum 2 weeks sustained abstinence,
- completed first 2 weeks of treatment at Wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site,
- priority will go to participants who are from or moving back to a rural area or small town defined as a population less than 10,500,
- agree to be audio recorded in group meetings and in individual meetings with research staff,
- currently are clients in the Wayside residential program,
- participants must be English speaking and literacy must be strong enough to write short lists and to understand the questions asked in the questionnaires.
- Priority will go to women who will be residing at Wayside for the duration of the study activities (and not moving out after one week, for example).
Exclusion Criteria:
- presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study;
- severe psychiatric illness (current schizophrenia, major depression with suicidal ideation);
- personality disorders that would interfere with satisfactory participation in or completion of the study protocol,
- inability to give informed, voluntary consent to participate,
- lack of sufficient English literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items,
- any impairment, activity, or situation that in the judgement of the research staff would prevent satisfactory participation in or completion of the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Treatment Group
Positive Peer Journaling (PPJ)
|
PPJ is a journaling practice to support addiction recovery.
PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse.
PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists.
On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful.
Wishes for others are also expressed on this page.
On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Retention
Time Frame: 8 weeks
|
Percentage of participants who were retained in treatment at the host facility until the end of the study or who left the residential treatment facility on good terms during the course of the study.
|
8 weeks
|
|
Substance Use
Time Frame: 8 weeks
|
Evidence that the individual used drugs or alcohol during the intervention period.
This will be assessed via positive drug screen (urine test or breathalizer) or participant self-report of substance use.
Reported as the number of participants who use illicit substances during the study.
|
8 weeks
|
|
Percentage of Group Sessions Attended
Time Frame: 8 weeks
|
Percentage of group sessions will be calculated by taking the number of group sessions attended divided by total number of group sessions offered.
Outcome is reported as the overall percentage of group attendance for all 15 participants combined.
|
8 weeks
|
|
Number of PPJ Journal Entries Made
Time Frame: 8 weeks
|
Total count of the number of PPJ journal entries made over the course of the study
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Krentzman, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 29, 2019
Primary Completion (ACTUAL)
September 30, 2019
Study Completion (ACTUAL)
September 30, 2019
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (ACTUAL)
April 4, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 26, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004619
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Addiction
-
Gazi UniversityCompletedInternet Addiction | Game Addiction, VideoTurkey
-
Artvin Coruh UniversityRecruitingParenting | Social Media Addiction | Internet AddictionTurkey
-
Mersin UniversityÇankırı Karatekin University; Scientific and Technological Research Council...CompletedInternet Addiction | Smartphone Addiction | Technology AddictionTurkey (Türkiye)
-
Zagazig UniversityActive, not recruitingInternet Addiction | Gaming Disorder | Porn AddictionEgypt
-
Chengdu Sport UniversityNot yet recruitingInternet Addiction Disorder
-
The Hong Kong Polytechnic UniversityRecruiting
-
Cumhuriyet UniversityCompletedRisk Behavior | Social Media Addiction | Internet Addiction
-
Kafrelsheikh UniversityRecruiting
-
Karabuk UniversityCompleted
-
Kutahya Health Sciences UniversityCompleted
Clinical Trials on Positive Peer Journaling (PPJ)
-
University of MinnesotaCompletedAddictionUnited States
-
Milton S. Hershey Medical CenterPenn State UniversityCompleted
-
Mayo ClinicTerminatedResilience, Psychological | Psychology, Positive | Positive ThinkingUnited States